A Randomized Controlled Trial Evaluating Safety and Efficacy of Sodium Hyaluronate and Carboxymethylcellulose at Cesarean Delivery

INTRODUCTION: To determine if placement of a sodium hyaluronate and carboxymethylcellulose adhesion barrier at cesarean delivery reduces adhesion formation at subsequent cesarean delivery. We previously reported data showing no increase in short-term complications. METHODS: Seven hundred fifty-three patients were evaluated in this multicenter, randomized study. Patients undergoing primary and repeat cesarean deliveries were randomized into either sodium hyaluronate and carboxymethylcellulose (n=380) or a no-treatment group (n=373). The location and density of adhesions (primary outcome) were assessed at their subsequent delivery using a validated tool, which has a score from 0 to 12. Secondary outcomes included safety and operative times. Sixty-five patients returning for a subsequent delivery from each arm were required to show a 50% reduction in adhesions. RESULTS: No differences in baseline characteristics, postoperative course, or incidence of complications between the groups after randomization were noted. Eighty patients from the sodium hyaluronate and carboxymethylcellulose group and 92 patients in a control group returned for subsequent deliveries. Adhesions in any location were reported in 75.6% of the sodium hyaluronate and carboxymethylcellulose group and 75.9% of the women in the control group (P=.99). There was no significant difference in the median adhesion score: 2 (range 0-10) for the sodium hyaluronate and carboxymethylcellulose group compared with 2 (range 0-8) for the control group (P=.65). There were no significant differences in the time from incision to delivery (P=.56). Uterine dehiscence in the next pregnancy was reported in two patients in the sodium hyaluronate and carboxymethylcellulose group compared with one woman in the control group (P=.60). CONCLUSION: Sodium hyaluronate and carboxymethylcellulose adhesion barrier applied at cesarean delivery does not reduce adhesion formation at the subsequent cesarean delivery. Although we did not demonstrate efficacy for improving adhesion formation, we did not identify safety concerns